FDA 483 - FinVector Oy

FinVector Oy, a drug substance and drug product manufacturer in Kuopio, Finland, was inspected by the FDA in January 2020. The inspection revealed significant deficiencies across its pharmaceutical quality system, including inadequate QA oversight, poorly defined quality procedures, unqualified assays, and issues with aseptic operations, cleaning, disinfection, and data management. These findings indicate a lack of robust controls and validation, potentially impacting product quality and safety.